Prostate CancerNCT01777061
Clinical Management Decisions for Recurrent Prostate Cancer Patients Based on [11C]Acetate PET Scan
A study testing [11C]Acetate in people with Prostate Cancer, run by Wendell Yap, MD at 1 site in United States.
Trial summary
When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes, but are not specific as to whether the lymph nodes are malignant or benign. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- [11C]Acetate
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive for recurrent prostate cancer by PSA criteria
- Recurrence definition:
- Status post-operative radical prostatectomy, recurrence is defined by a PSA of greater than or equal to 0.2 ng/ml
- Patients who have failed external beam radiation, or status post-brachytherapy, have recurrence as defined as PSA above 2.0 ng/ml the nadir PSA after treatment
- Subject is able to comprehend the study objectives and provide written informed consent before the initiation of any study-related procedures.
Who cannot join
- Eastern Cooperative Oncology Group (ECOG) status of ≥ 2
- Any other concurrent malignancy
- Patients without remission of disease (no PSA decrease)
- Patients without recurrence of disease (PSA remains low)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Clinical Management Decisions Based on [11C]Acetate Positron Emission Tomography Performed on Prostate Cancer Patients With Biochemical Recurrence
When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes, but are not specific as to whether the lymph nodes are malignant or benign.
While positron emission tomography (PET) utilizing radioactive glucose (FDG) has revolutionized staging, restaging, and monitoring response to therapy in many prevalent cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma, findings with prostate cancer have proven less sensitive because prostate cancer has a lower avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in detecting prostate cancer.
This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in identifying recurrent prostate cancer.
Read the detailed description
FDG-PET imaging uses a form of radioactive glucose (18-fluoro-deoxyglucose or FDG), which allows the measurement of glucose metabolic rate of any tissue in the body. The most prevalent tumors have a glucose avidity that is typically greater than 2.5 times the avidity of benign tissue. Therefore, FDG-PET is able to discriminate between benign lymph nodes and those containing metastases, and similarly between scar tissue and recurrence of tumor.
Unfortunately, prostate cancer is only minimally glucose avid, and therefore, FDG-PET is much less effective in staging prostate cancer. The current FDA-approved imaging agent for prostate cancer is a monoclonal antibody specific for prostate cancer cells, capromab pendetide, labeled with a long-lived radionuclide [111]Indium that is used to image the patient over a six day period. However, recent data show that another PET radiopharmaceutical, [11C]Acetate (which has been FDA approved for years for cardiac imaging), is avidly taken up by prostate metastasis and is more sensitive than either [111]Indium capromab pendetide or FDG-PET.
This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in identifying recurrent prostate cancer and aim to find at what PSA levels it is most effective.
- Conditions
- Prostate Cancer
- Being tested
- [11C]Acetate
- Keywords
- Prostate Cancer, Recurrent Prostate Cancer, PET Scan, FDG-PET, [11C]Acetate, C11-Acetate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]AcetateDrug
Also called carbon-11 acetate [[11C]acetate], sodium acetate [11C]Acetate injection
intravenous injection of an average of 40 mCi of [11C]Acetate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Wendell Yap, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Sponsor-investigator, Wendell Yap, MD, University of Kansas Medical Center
- Investigators
- Wendell Yap, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777061
- Sponsor's protocol ID
- 13429
- Status last verified
- May 2018
- First submitted
- 17 Jan 2013
- Last updated
- 16 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Management Decisions Based on [11C]Acetate Positron Emission Tomography Performed on Prostate Cancer Patients With Biochemical Recurrence
- ClinicalTrials.gov ID
- NCT01777061
- Acronym / sponsor ID
- 13429
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Recurrent Prostate Cancer, PET Scan, FDG-PET, [11C]Acetate, C11-Acetate
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Wendell Yap, MDUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes, but are not specific as to whether the lymph nodes are malignant or benign.
While positron emission tomography (PET) utilizing radioactive glucose (FDG) has revolutionized staging, restaging, and monitoring response to therapy in many prevalent cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma, findings with prostate cancer have proven less sensitive because prostate cancer has a lower avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in detecting prostate cancer.
This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in identifying recurrent prostate cancer.
Detailed description
FDG-PET imaging uses a form of radioactive glucose (18-fluoro-deoxyglucose or FDG), which allows the measurement of glucose metabolic rate of any tissue in the body. The most prevalent tumors have a glucose avidity that is typically greater than 2.5 times the avidity of benign tissue. Therefore, FDG-PET is able to discriminate between benign lymph nodes and those containing metastases, and similarly between scar tissue and recurrence of tumor.
Unfortunately, prostate cancer is only minimally glucose avid, and therefore, FDG-PET is much less effective in staging prostate cancer. The current FDA-approved imaging agent for prostate cancer is a monoclonal antibody specific for prostate cancer cells, capromab pendetide, labeled with a long-lived radionuclide [111]Indium that is used to image the patient over a six day period. However, recent data show that another PET radiopharmaceutical, [11C]Acetate (which has been FDA approved for years for cardiac imaging), is avidly taken up by prostate metastasis and is more sensitive than either [111]Indium capromab pendetide or FDG-PET.
This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in identifying recurrent prostate cancer and aim to find at what PSA levels it is most effective.
Study design
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive for recurrent prostate cancer by PSA criteria
- Recurrence definition:
- Status post-operative radical prostatectomy, recurrence is defined by a PSA of greater than or equal to 0.2 ng/ml
- Patients who have failed external beam radiation, or status post-brachytherapy, have recurrence as defined as PSA above 2.0 ng/ml the nadir PSA after treatment
- Subject is able to comprehend the study objectives and provide written informed consent before the initiation of any study-related procedures.
Key exclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) status of ≥ 2
- Any other concurrent malignancy
- Patients without remission of disease (no PSA decrease)
- Patients without recurrence of disease (PSA remains low)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]AcetateAlso: carbon-11 acetate [[11C]acetate], sodium acetate [11C]Acetate injectionintravenous injection of an average of 40 mCi of [11C]Acetate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendell Yap, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [11C]Acetate in people with Prostate Cancer, run by Wendell Yap, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.